Government stops all manufacturing activities of Maiden Pharmaceuticals, forms committee

The Union Ministry of Health on Wednesday, 12 October, announced that all the manufacturing at Maiden Pharmaceuticals was being stopped.

BySumit Jha

Published Oct 13, 2022 | 4:38 PMUpdatedOct 13, 2022 | 4:40 PM

The Central government stopped all Maiden Pharma operations with immediate effect under Section 22(1d) of the Drugs and Cosmetics Act of 1940, and rules framed thereunder.

The Union Ministry of Health and Family Welfares on Wednesday, 12 October, announced that all the manufacturing activities of Maiden Pharmaceuticals were being stopped with immediate effect under Section 22(1d) of the Drugs and Cosmetics Act of 1940, and rules framed thereunder, till further order.

It added that this was being done in the public interest, without prejudice to further action in the matter.

The ministry also formed a panel under Dr YK Gupta, the vice-chairman of the Standing Committee on Medicine, on the Gambian deaths due to cough syrups supplied by Maiden Pharmaceuticals.

The committee also comprises, Dr Pragya D Yadav, NIV, ICMR-Pune; Dr Arti Bahl Division of the NCDC in New Delhi; and AK Pradhan, Joint Drugs Controller, CDSCO.

The committee may co-opt any other technical expert as deemed necessary.

After examining and analysing adverse event reports, causal relationships and all related details shared by WHO, the committee will suitably advise and give recommendations to the Drugs Controller General of India (DCGI) about the further course of action.

The death of 69 children in West Africa’s Gambia from kidney-related complications was linked to four cough-and-cold syrups manufactured by Indian company Maiden Pharmaceuticals Limited.

The WHO said that laboratory analysis of the samples of each of the four cough syrups in question confirmed that they contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.

The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup.

The Central Drugs Standard Control Organisation (CDSCO) took up the matter immediately with the Haryana State Regulatory Authority, under whose jurisdiction the drug manufacturing unit of Maiden Pharmaceutical Limited is located.

The CDSCO launched a detailed investigation and did a local inspection of the manufacturing premises on 1, 3, 8, and 11 October to ascertain details in collaboration with the State Drugs Controller of Haryana.

Meanwhile, samples of the same batch manufactured by Maiden Pharmaceuticals Limited for all four drugs in question were sent for testing to Regional Drug Testing Lab, Chandigarh by CDSCO, the results of which are awaited.

The CDSCO and the State Drug Controller stopped all the manufacturing activities of Maiden Pharmaceuticals Limited at Sonepat on 11 October on grounds of deficiencies found in the local inspection.